It was reported that the procedure was to treat a lesion located in the left anterior descending coronary artery that was moderately calcified and mildly tortuous.Reportedly, the xience sierra des 2.75x23 rx stent delivery system (sds) met resistance with another non-abbott stent during crossing.The stent dislodged; however, was retrieved with the sds balloon which was still in the anatomy.The stent was removed elongated with the sds balloon.The lesion was dilated and a different stent was deployed to complete the procedure.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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A visual inspection was performed on the returned device.The reported stent dislodgement and stretched stent was confirmed.The reported failure to advance could not be evaluated as the exact anatomical conditions encountered by the device used during the procedure could not be replicated in the test laboratory.The electronic lot history record and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to the operational context of the procedure, as it is likely that the xience sierra interacted with a previously implanted, non-abbott stent during advancement, causing the reported failure to advance.Further interaction with the previously implanted stent in addition to the challenging anatomy during retraction of the device, as resistance was noted, likely contributed to the reported stent dislodgement, ultimately causing the reported stretched stent and observed material deformation (stent damage).There is no indication of a product quality issue with respect to manufacture, design, or labeling.D4: correction ¿ lot# updated from 213104b to 203104b.
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